Device product
GE Healthcare Optima XR 220amx 30kw Mobile X-ray System The GE Automatic Mobile X-Ray (AMX) Series: Brivo XR2S5amx, Optima XR200amx, Optima XR22Oamx are intended to take exposures utilizing film or computed radiography (CR), however the Optima XR22Oamx utilizes the GE Wireless Detector, which is intended to replace radiographic film screen systems in all general purpose diagnostic procedures, for digital radiography (DR).
Z-0448-2013
Product summary
- Event
- Event 63212
- Status
- Terminated
- Classification
- Class II
- Quantity
- 217 total Installed in the US
- Official record key
device-enforcement:Z-0448-2013
Official wording
Reason: GE Healthcare has become aware of a software issue on the interface of the mobile radiographic product, Optima XR22Oamx and Optima XR200amx with Digital Upgrade.
Code information: Model No - 5555000-5
Distribution pattern: Nationwide distribution
Derived failure modes
-
Device software or design
software issue